US-based Moderna expects interim results from its covid vaccine trials next month. And if the company gets interim positive results from the large clinical trial, the US government could authorize emergency use of the company’s experimental Covid-19 vaccine in December, its chief executive said.
During The Wall Street Journal’s annual Tech Live conference on Monday, Chief Executive Stephane Bancel said that if it takes longer to get enough interim results from the study, government clearance of the vaccine may not come until early in the year. next year.
Modern, based in the US, has one of the leading Covid-19 vaccines in development, along with a vaccine jointly developed by Pfizer Inc and BioNTech.
Last week, Pfizer Inc had said it could apply by the end of November for US authorization for the COVID-19 vaccine it is developing. “Let me be clear, assuming positive data, Pfizer will apply for the use of emergency authorization in the US shortly after the safety milestone is achieved in the third week of November,” said Pfizer CEO Albert Bourla. .
The United States government’s Operation Warp Speed program has spent billions of dollars developing vaccines and treatments.
In July, Moderna began a study of 30,000 people in the US to test its vaccine candidate.
In the trial, half of the study subjects receive the vaccine and the other half receive a placebo, and the researchers then count how many develop symptomatic Covid-19.
That first analysis is likely to occur in November, but “it is difficult to predict exactly in which week because it depends on the cases, the number of people who get sick,” Moderna CEO Bancel said.
Moderna had said earlier this month that it will soon request real-time reviews of its experimental COVID-19 vaccine in Europe, days after the EU health regulator released continuous reviews of its rivals’ injections.
The drug developer said it was in talks with European countries and would send the same data that it plans to send to the US Food and Drug Administration for authorization.
The European Medicines Agency this month launched real-time reviews of the COVID-19 vaccines being developed by US drugmaker Pfizer and Germany’s BioNTech, following a similar announcement for AstraZeneca.
(With contributions from the agency)
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